Cold contact urticaria MedDRA version: 14.1 Level: LLT Classification code 10009869 Term: Cold urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Rupafin
Pharmaceutical Form: Tablet
INN or Proposed INN: Rupatadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the place
Sponsors
Allergie-Centrum Charité
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent signed and dated. • Reliable method of contraception for women of childbearing potential during the study and 3 months thereafter. • Outpatients with CCU for more than 6 weeks confirmed by positive response with wheal and itch on Temptest®. • Age 18 and above years. • No participation in other clinical trials 1 month before and after participation in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz). • The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria. • The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract). • History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia. • History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. • ECG alterations of repolarisation (QTc prolongations > 450ms). • Blood pressure >180/100 mmHg and/or heart rate >100/min. • Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value). • History of hypersensitivity or allergic reaction to rupatadine or any other antihistamine compounds. • Presence of active cancer which requires chemotherapy or radiation therapy. • Presence of lactose and galactose intolerance or glucose-galactose malabsorption. • Simultaneous chronic spontaneous or physical urticaria that could interfere CCU clinical assessment. • Intake of antihistamines or antileukotrienes within 7 days before beginning of the study. • Intake of oral or depot corticosteroids within 14 days prior to screening visit. • Use of systemic immunosupressants/immunomodulators like cyclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit. • Use of ketoconazole, erythromycin or potential inhibitors of the isoenzyme CYP3A4 of the cytochrome P450. • Currently abusing drugs or alcohol. • Unwilling or unable to comply with the protocol. • Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of rupatadine 20 mg and 40 mg on symptom development during the induction of skin lesions in CCU patients challenged with defined temperatures using Temptest® 3.0;Secondary Objective: To assess the effects of rupatadine on mast cell mediator release in blood during the induction of skin lesions in CCU patients challenged with cold water bath provocation with defined temperatures. Mediator measurements will include histamine and other mast cell-derived inflammation markers (e.g. PAF/LysoPAF, PGD2) To assess the effect of rupatadine on mast cell activation in the skin of CCU patients To assess the safety and tolerability of rupatadine;Primary end point(s): - Change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of rupatadine (20 mg and 40 mg) measured by Temptest® 3.0;Timepoint(s) of evaluation of this end point: Visit 2, Visit 3, Visit 4, Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in mast cell mediator release, including histamine, PAF/LysoPAF and PGD2 after treatment with rupatadine (20 and 40 mg) compared to placebo - Change in mast cell activation (measured by intracutaneous codeine,histamine, PAF and saline injection) - Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting;Timepoint(s) of evaluation of this end point: Visit 3, Visit 4, Visit 5 | — |
Countries
Germany, Spain
Contacts
Public ContactAllergie-Centrum Charité
Charité-Universitätsmedizin Berlin
Outcome results
None listed